Quality Assurance Manager - Oregon, United States - Serán Bioscience, LLC

Description

Serán BioScience is seeking a Quality Assurance Manager to oversee the day-to-day operations of the Quality Assurance department.

Required attributes include a results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management.

Experience with analytical laboratory or manufacturing operations is desired.

Successful candidates will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.

Preference given to candidates who have proven leadership abilities with greater years of experience and broad knowledge and of FDA and international regulations related to GMP within a pharmaceutical manufacturing setting.

Supervisory Responsibilities

Leads and mentors Quality Assurance personnel
Provides constructive and timely performance evaluations
Handles discipline of employee in accordance with company policy
Hires, trains, and mentors new staff members
Duties and Responsibilities

Oversees management and scheduling of department operations
Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing
Identifies critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments
Performs document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
Oversees of a broad range of documentation including, but not limited to User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Control, and Risk Assessments
Support internal audits, client audits and regulatory inspections, as needed
Work with cross-functional teams to troubleshoot equipment, process, testing, and validation issues
All other duties as assigned
Required Skills and Abilities

Broad knowledge FDA and international regulations related to GMPs and Pharmaceuticals
Experience organizing and managing work responsibilities while working independently with minimal oversight
Time and project management skills with the ability to multi-task and meet deadlines
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
Strong supervisory and leadership skills
Ability to prioritize tasks and to delegate them when appropriate
Proficient with Microsoft Office Suite or related software
Education and Experience

Minimum of a bachelor's degree, preferably in a scientific discipline
5+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
Experience with regulatory inspections by the FDA and EU authorities is desired
Physical Requirements

Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 15 pounds at times

#J-18808-Ljbffr